BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

    Reg #: 1828100 · FEI: 1828100 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    24
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Registration Number
    1828100
    FEI Number
    1828100
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6200 Jackson Road
    City
    ANN ARBOR
    State
    MI
    ZIP
    48103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234065

    Owner / Operator

    Firm Name
    Terumo Cardiovascular Systems Corp.
    Operator Number
    10039199
    Address
    6200 Jackson Road
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Lisa Hessabi

    Products

    Device Name Product Code
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Console, Heart-Lung Machine, Cardiopulmonary Bypass DTQ
    Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass DTY
    Pump, Blood, Cardiopulmonary Bypass, Roller Type DWB
    Control, Pump Speed, Cardiopulmonary Bypass DWA
    Controller, Temperature, Cardiopulmonary Bypass DWC
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Alarm, Blood-Pressure DSJ
    Computer, Blood-Pressure DSK
    Tubing, Pressure And Accessories BYX
    Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass DTW
    Detector, Bubble, Cardiopulmonary Bypass KRL
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Blade, Saw, General & Plastic Surgery, Surgical GFA

    Proprietary Names

    CDI OneView Monitoring System Advanced Perfusion System 1 CDI (TM) SYSTEM 100 MONITORING SYSTEM Terumo Advanced Perfusion System 1 Roller Pump for the Terumo Advanced Perfusion System 1 Pump Speed Controller CDI BLOOD PARAMETER MONITORING SYSTEM 500 ADVANCED PERFUSION SYSTEM 1 TEMPERATURE CONTROL & MONITOR Pump SAMS 8000 Pressure Tubing SARNS 8000 MODULAR PERFUSION SYSTEM LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 Blade SARNS CDI Blood Parameter Monitoring System 550 SARNS Flow Sensor SARNS DELPHIN BASE ADAPTER WITH BATTERY HLM SARNS 9000 UNIVERSAL ROLLER PUMP SARNS 800 ROLLER PUMP CPB Accessory SARNS ULTRASONIC AIR SENSOR

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only